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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 16

Sandvik Hard Materials

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: Cemented carbide formulated as follows: Tungsten Carbide(WC) - 95%, Carbides of titanium, tantalum and niobium - 5%, Cobalt(Co) - 0.5%-1%
Notifier: AB Sandvik Hard Materials
Manufacturer/Supplier: Sandvik Hard Materials
Intended Use: For use in seal rings and bearings for food processing equipment including pumps.
Limitations/Specifications*: For use in contact with all types of food, in the pH range >2.
Effective Date: Apr 4, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)